Hahn Meets Praise, Resistance During FDA Confirmation
FDA commissioner nominee Stephen Hahn sailed through his Senate confirmation hearing 11/20 with praise and some resistance from lawmakers. Senate Health, Education, Labor & Pensions chair Lamar Alexander (R-TN) called Hahn an “impressive choice” to lead FDA. “This is a critical time for FDA, and there is a lot that FDA needs to do – review and approve lifesaving drugs and devices, regulate tobacco and e-cigarettes, complete the ongoing lung injury investigation, protect our nation’s food supply, and continue addressing the opioid crisis,” Alexander said. “As an oncologist, you know firsthand the importance of bringing new, life-saving drugs and devices quickly through the regulatory process. And as a successful chief executive, you will bring a guiding hand to an agency tasked with protecting the public’s health.”
During his opening statement, Hahn pledged, if confirmed, to be “guided by the core values of integrity and transparency, and I promise to put the interests of the American people first. As a front-line cancer physician, researcher, and executive at an academic medical center, I am profoundly aware of the importance of the FDA’s role in the health and welfare of the American people... I believe strongly in the importance of science, data, and the law that have guided and should continue to guide the decision-making at the FDA... There are many issues that will likely come before the commissioner that are perplexing and engender honest disagreement. When that occurs, I pledge to listen, study and assess all viewpoints.”
Ranking member Patty Murray (D-WA) told the hearing that Hahn’s vetting is extremely important because of president Trump’s poor track record when it comes to putting forward nominees, such as nominating those with ethical problems, conflicts of interest, and little or no experience for the position at hand. She said that with Hahn, she has reservations due to his lack of government experience, no public record on policy issues related to FDA and no experience leading an organization as complex as the agency.
During questioning, Murray pressed Hahn on his commitment to putting science, data, and families’ health ahead of ideology, politics, and companies’ profits. Hahn said that throughout his career he has made decisions based on data and science, “congruent with law.” Asked to opine on the president’s recent reversal on e-cigarettes and vaping (see earlier story), Hahn emphasized his lung cancer treatment experience and said he is aware of the data showing that their use among children is at crisis level and aggressive action is needed to curb the growing use. He acknowledged that a final compliance policy is still under consideration by the administration and that he is not privy to those deliberations. Murray further asked whether he told the president that he disagrees with any plans to back away from promised e-cigarette actions, Hahn responded that he had not spoken with the president.
During her opening statement, Murray said she was “alarmed by changes the Trump Administration has proposed to FDA’s medical device review program including a proposal to pre-certify software developers, and a decision to apparently break a commitment it made to me to limit a conditional approval pathway to certain animal drugs — by expanding it to human medical products as well. I’m concerned these proposals are not consistent with the FDA’s gold standard and may compromise patient safety — and I expect Dr. Hahn to revisit them if confirmed.”
Concern about FDA’s protection from political interference was also on the mind of Sen. Mitt Romney (R-UT), who asked Hahn if FDA under his leadership could act on issues without influence from the White House. Hahn said that under his leadership patients will come first and decisions will be guided by data and science congruent with the law. Romney criticized the administration’s delay on e-cigarettes and warned that increased lobbying will be directed at preventing any ban on flavored e-cigarettes.
Susan Collins raised drug shortages as a top priority for FDA to address and asked Hahn to commit to working with Congress to explore more ways to address shortages. Hahn said he would look forward to working with Congress to address this. Collins also brought up patent gaming by biologic firms attempting to stall market entry of approved biosimilars. Hahn pledged to work with congress to explore transparency initiatives under the Purple Book and to work toward eliminating anti-competitiveness practices.